What Is the Role of Real World Evidence in Clinical Trials?

Read World Data or Real World Evidence has almost become a buzzword in the clinical research space, kind of like patient-centricity and decentralization. But what does it really mean and why is it important? What follows is an interview with Maya Zlatanova for the Real-World Evidence event she participated in last year.

Could you introduce yourself, your institution, and your work?

My name is Maya Zlatanova, CEO of FindMeCure Ltd. I am a health tech entrepreneur, clinical research expert, and pharma industry speaker. I have 15 years of experience in clinical research regulations, patient recruitment, and engagement, clinical trial feasibility, and operations. What inspires me most are stories, not just facts, and I believe the clinical research industry has many stories every day that are calling for a change in the way we think and operate. Seasoned speaker at Clinical Trial Innovations, Scope Summit, Logipharma events, Patient Engagement Forum, GIANT Health etc.

What is the importance of patient and/or stakeholder engagement in designing clinical trials?

Designing a clinical trial goes through the protocol developing aspect. I have personally witnessed protocols structured in a way that either no such patient exists (when we combine indication with eligibility criteria) or the clinical trial schedule is absolutely impossible to comply with if you are a patient with pain, away from the site, working, with kids etc. This calls for an urgent patient and caregiver engagement.

On the other side, patient communities found out that they can no longer grow and have a real impact without learning how to be more helpful to companies. Many of them have already started education and preparation for that. Pharma companies also realized that they are at a moment where their customers – the patients, have a lot more freedom to choose and decide what’s best for their health. Knowing what they want and how they want it is an essential part of rethinking their strategy. 

I am excited to see people finally sit together and really try to overcome challenges because they understand that if we don’t do it together, then it won’t ever happen. And patient engagement is so important for society but also for the future of pharma that there is no other way.

What is the importance of using real-world evidence to effectively locate and recruit patients for trials, especially in the rare diseases field?

One of the main jobs of clinical trial planning is defining which locations and sites will recruit and monitor patients. If you have selected the wrong ones, this will result in a lack of patients recruited. 40% of sites today recruit 1 or 0 patients. In order to prevent this it is essential to know where patients are located, why they would participate in a study, and how to help them be monitored at their convenience, following their lifestyle and specific condition requirements. This is where RWE can help the most.

Without giving too much away, what do you hope are the key points for the audience to take away from your talk at Real-World Evidence 2020: Rare Diseases and Innovative Therapies? 

–         What makes rare diseases special in terms of patient recruitment and how RWE can help?

–         What kind of RWE data is out there?

–         Tricks and hacks to use RWE data that you can use for designing your clinical trial?

Why do you think events like Real-World Evidence 2020: Rare Diseases and Innovative Therapies are important in progressing the field?

It’s important to exchange know-how in areas that are so important to us. Patient recruitment is a huge challenge for everyone. Sponsors are trying more and more to improve their GO/NO GO decision-making process and avoid clinical trial delays and failures.

It’s proven that knowing the patients’ pathway in each country gives you essential points to consider why you should expect challenges with recruiting and maintaining patients in the clinical trial. With rare diseases, this aspect is next level, as we speak about a lot fewer patients in terms of numbers spread across the world, so there is almost no room for mistakes. 

In 2020, rare diseases continued to grow In East Asia and in Q1 of this year, it was the second best recovering TA after Ophthalmology. If you’d like to learn more about it and other TAs as well as geographical regions in 2021, you can check out our Market Overview.

First published on LinkedIn.

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